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Trial record 20 of 27 for:    dutasteride AND tamsulosin

Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia (PARTEM)

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ClinicalTrials.gov Identifier: NCT02869971
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE August 17, 2016
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE August 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
Change in IPSS score [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Number of Adverse Events [ Time Frame: 3, 9, 18, 24 months ]
  • IPSS [ Time Frame: 3, 18, 24 months ]
  • Qmax [ Time Frame: 3, 9, 24 months ]
  • International Index of Erectile Function (IIEF) score [ Time Frame: 3, 9, 18, 24 months ]
  • prostate volume [ Time Frame: 3, 9, 24 months ]
  • Prostate-Specific Antigen (PSA) level [ Time Frame: 3, 9, 18, 24 months ]
  • Quality of life score [ Time Frame: 3, 9, 18, 24 months ]
    assessed by IPSS/Quality of Life (QoL) form
  • Treatment units' account [ Time Frame: 3, 9 months ]
    adherence to treatment
  • Adherence to treatment questionnaire [ Time Frame: 3, 9 months ]
    adherence to treatment
  • number of PAE [ Time Frame: 24 months ]
  • number of surgical treatment [ Time Frame: 24 months ]
  • number of medication [ Time Frame: 3, 9, 18, 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Number of Adverse Events [ Time Frame: 3, 9, 18, 24 months ]
  • IPSS [ Time Frame: 3, 18, 24 months ]
  • Qmax [ Time Frame: 3, 9, 18, 24 months ]
  • International Index of Erectile Function (IIEF) score [ Time Frame: 3, 9, 18, 24 months ]
  • prostate volume [ Time Frame: 3, 9, 18, 24 months ]
  • Prostate-Specific Antigen (PSA) level [ Time Frame: 3, 9, 18, 24 months ]
  • Quality of life score [ Time Frame: 3, 9, 18, 24 months ]
    assessed by IPSS/Quality of Life (QoL) form
  • Treatment units' account [ Time Frame: 3, 9 months ]
    adherence to treatment
  • number of PAE [ Time Frame: 24 months ]
  • number of surgical treatment [ Time Frame: 24 months ]
  • number of medication [ Time Frame: 3, 9, 12, 18, 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
Official Title  ICMJE Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
Brief Summary

The primary objective of this trial is to compare the 9-month effect on lower urinary tract symptoms (LUTS) of Prostatic Artery Embolization (PAE) using Embosphere® versus Standard Combined Therapy (alpha-blockers plus 5 alpha-reductase inhibitors) in patients with symptomatic BPH who failed after a first line medical treatment with alpha-blockers.

The secondary objectives of this study are to:

  • Estimate the impact of the 2 strategies on benign prostatic hyperplasia specific Health Status (i.e. urinary and sexual signs and symptoms) at 3, 9, 18, and 24 months, as well as the side effects of the 2 strategies;
  • Report the safety of PAE;
  • Evaluate patient's adherence to medical treatment;
  • Analyse the costs of each strategy and report the incremental efficiency (incremental cost utility ratio) of prostatic artery embolization compared to medical treatment.
Detailed Description

Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS) and affects > 50% of men >60 years. Moderate to severe symptoms prevalence is around 14% in France, and the proportion of men with moderate to severe symptoms doubles with each decade of age. The first-line treatment of bothersome BPH-related LUTS is medical therapy as recommended by French and European guidelines. 5α reductase inhibitors (5-ARI) can be combined with alpha-blockers and allow reduction of the size of the prostate and LUTS improvement. The severity of symptoms is usually assessed using the International prostate symptom score (IPSS) which is the standard questionnaire for the objective assessment of LUTS.

Recently, Prostatic Artery Embolization (PAE) has been proposed to treat symptomatic BPH with good safety and efficacy in single-centre studies (12-point IPSS reduction at 3 months maintained up to one year. In a randomized trial comparing PAE versus transurethral resection of prostate (TURP), Gao reported a 16-point IPSS reduction at 6 months, and an increase in the maximum urinary flow rate (Qmax) comprised between 12 ml/s and 24 ml/s at 6 months and up to 21 ml/s at 2 years. The complication rate is low (a few cases of bladder ulcer have been published) and the patient generally experiences mild post-embolization symptoms for few days.

PAE can be performed during a one-day hospitalisation and could be very attractive to patients which have insufficient benefit of medical treatment or who have side effects affecting their quality of life. The most used device for PAE is Embosphere® (Merit Medical). It bears the European CE (Conforme aux Exigences) marking for this specific indication and approximately 500 patients have been treated with it worldwide. Nonetheless, no big randomized study has proven its efficacy compared with best medical treatment. A study comparing PAE using Embosphere® and surgery (TURP) is currently enrolling patients; no patients could be included in France because men with BPH refused to be potentially assigned the surgical arm.

To properly evaluate PAE, the investigators designed the PARTEM trial, which has received the support of both the Societe Francaise de Radiologie (French society of radiology) and of the Association Francaise d'Urologie (French association of urology).

PARTEM will compare prospectively the benefit of PAE using Embosphere® to the benefit of combined medical treatment (Combodart®: Dutasteride 0.5mg Tamsulosin 0.4mg) at 9 months with an extended follow up at 24 months in order to evaluate the stability of results in both groups.

The investigators plan a multicentre, prospective, randomized, open label, parallel trial, comparing PAE to Combined Therapy (CT: alpha-blockers + 5-ARI treatment). Treatments will be allocated by minimization with a 1:1 ratio, based on study centre, IPSS score (moderate/severe) and prostate volume (< 80 g/≥80 g).

This study is designed to demonstrate the superiority of PAE to decrease LUTS compared to best medical treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE
  • Device: Embosphere® (Prostatic Arteries Embolization)
    Prostatic Arteries Embolization with 300-500 µm trisacryl microspheres
  • Drug: Drug therapy
    Combodart (dutasteride 0.5 mg/tamsulosin 0.4 mg)
Study Arms  ICMJE
  • Experimental: Embolization
    Prostatic Arteries Embolization
    Intervention: Device: Embosphere® (Prostatic Arteries Embolization)
  • Active Comparator: Combined Therapy
    Combodart® : dutasteride 0.5 mg/tamsulosin 0.4 mg per day
    Intervention: Drug: Drug therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men aged>= 50 and <=85 years AND
  • Moderate to severe LUTS defined as IPSS > 11, and QoL > 3 AND
  • No improvement after an alpha blocker treatment line (Tamsulosin 0.4 mg p.d. during 1 month) AND
  • Prostatic volume >=50 ml AND
  • Affiliated to a French health insurance system

Exclusion Criteria:

  • Severe allergy to iodine contrast agent
  • Treatment with 5-ARI on the last 6 months
  • Suspected prostate cancer requiring specific management
  • On-going prostatitis
  • On-going urinary retention
  • On-going acute urinary infection
  • Acontractile detrusor
  • Neurogenic lower urinary tract dysfunction
  • Urethral stenosis
  • Bladder diverticulum
  • Bladder stone with surgical indication
  • Patient refusing PAE
  • Creatinine clearance <40 ml/min
  • Severe liver failure
  • Contra-indication to alpha-blockers
  • Hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin (including case of tamsulosin induced angioedema), soya, peanut or one of the excipients
  • Hypersensitivity to gelatin or collagen
  • Patients ineligible for pelvic angiography
  • History of orthostatic hypotension
  • Patient unable or unwilling to provide written informed consent
  • Patient under legal protection
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marc Sapoval, MD marc.sapoval2@aphp.fr
Contact: Yvann FRIGOUT yvann.frigout@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02869971
Other Study ID Numbers  ICMJE P150917
PHRC-15-521 ( Other Grant/Funding Number: French ministry of Health )
2016-A00247-44 ( Other Identifier: France: ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Marc Sapoval, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP